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202016 Resveratrol (JOT ROL) Gelcap Phase I Said Study 25NOV2020Jupiter Orphan TherapeuticsPROTOCOL 202016 IND Number: 132145 Amendment II A PHASE 1 STUDY TO ASSESS THE PHARMACOKINETICS AND SAFETY

How to fill out protocol amendment 2

How to fill out protocol amendment 2

1. Begin by thoroughly reviewing the existing protocol to understand the proposed changes and amendments.
2. Identify the specific sections or areas of the protocol that need to be modified.
3. Prepare a document outlining the amendments, clearly stating the rationale for each proposed change.
4. Follow the standard format for protocol amendments, including the title, introduction, and objectives.
5. Ensure that the revised protocol complies with any applicable regulations or guidelines.
6. Obtain necessary approvals from the required authorities or ethics committees.
7. Communicate the proposed amendments to all relevant stakeholders, including investigators and study site staff.
8. Provide clear instructions on how to implement the changes and ensure proper training is conducted.
9. Update the protocol amendment in the study documentation and maintain a record of each version.
10. Finally, distribute the updated protocol amendment to all parties involved in the research study.

Who needs protocol amendment 2?

1. Protocol amendment 2 may be required by researchers or sponsors who are conducting clinical trials or other research studies that involve human subjects.
2. It is necessary when changes or modifications are deemed necessary to the original protocol for various reasons, such as addressing safety concerns, incorporating new findings, or improving study design.
3. Additionally, regulatory authorities and ethics committees may request protocol amendments to ensure the study meets the necessary ethical and scientific standards.
4. Therefore, individuals involved in the planning, execution, or oversight of research studies may need to consider protocol amendment 2.

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What is protocol amendment 2?

Protocol amendment 2 is a revision or update to the original protocol for a study or research project.

Who is required to file protocol amendment 2?

The principal investigator or lead researcher is typically required to file protocol amendment 2.

How to fill out protocol amendment 2?

Protocol amendment 2 can be filled out by following the instructions provided by the Institutional Review Board or relevant governing body.

What is the purpose of protocol amendment 2?

The purpose of protocol amendment 2 is to ensure that any changes to the original protocol are documented and approved to protect the welfare of research participants.

What information must be reported on protocol amendment 2?

Protocol amendment 2 must include details of the proposed changes to the original protocol, rationale for the changes, and potential impact on research participants.